Belotero -New Filler is FDA Approved

Dr. Lawrence Bass | 01/12/2012

In December 2011, the FDA approved Belotero, an injectable filler manufactured by Merz Aesthetics, for the treatment of moderate to severe facial folds, like nasolabial folds. Several hyaluronate fillers have been added to the US marketplace since the initial approval of Restylane in 2004. Each hyaluronate filler is based on the same basic building block which represents the major constituent of the gel matrix in our connective tissues, including skin. However, each product is formulated differently (US products in widespread use are currently purified from bacterial broth and do not originate from animal sources). The nature of the cross-linking and physical state (gel vs particle) of the products results in subtle differences in mechanical properties of the fillers making them stiffer or softer. This in turn translates into each material being more suitable for deep or superficial applications based on how it spreads through tissues, how smooth the results are, and how good the material is at lifting or tenting tissues flat.

Belotero holds some promise as a more suitable filler for superficial applications like lip-stick bleed lines or lower eyelid smoothing (fill-in of tear trough, etc.) as well as in lip augmentation. Whether there will prove to be a significant advantage in practice will require a few months of use and followup, but my testing of the material outside the United States, where it was approved and available earlier, suggests that it holds a lot of potential.

Several forms of Belotero are available abroad, but only the mid-weight material, called Belotero Balance, is being introduced in the United States at this time. Actual availability of the product is probably 3-6 months away, but the formal FDA approval ensures that it is coming. Having more options helps plastic surgeons and other injectable providers produce the subtle, artful details that give the most complete correction while maintaining a natural appearance.